A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

Anemia Clinical Trial

Official title:

A Randomized, Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Control in Patients Transitioning From Chronic Kidney Disease Stage 4 Through Dialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00454246
• Other study ID #: ML20337
• Status: Terminated
• Phase: Phase 3
• First received: March 29, 2007
• Last updated: November 14, 2011
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: November 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic kidney disease stage IV not requiring dialysis;

• expected to initiate dialysis within 18 months;

• 15<=Glomerular Filtration Rate (GFR)<=29.

Exclusion Criteria:

• failing renal allograft in place;

• acute or chronic bleeding within 8 weeks prior to screening;

• transfusion of red blood cells within 8 weeks prior to screening;

• poorly controlled hypertension;

• immunosuppressive therapy in the 12 weeks prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
• epoetin alfa
Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
• darbepoetin alfa
Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL	Efficacy analyses were not performed.	6-7 months post initiation of dialysis	No
Secondary	Dose Adjustments	Efficacy analyses were not performed.	5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.	No
Secondary	Number of Participants Assessed for AEs and SAEs	The adverse events are captured in the adverse event and serious adverse event section of this database.	First dose of medication through 15 days post last dose (up to 8 months)	No